Changes in Diaphragmatic Activity Before and After Caffeine Citrate Administration and Discontinuation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- EDI change after caffeine citrate loading dose
研究概览
简要总结
Caffeine citrate, the first-line agent for apnea of prematurity, enhances diaphragmatic activity. EDI values of neurally adjusted ventilatory assist (NAVA) modes can be used to quantify the diaphragmatic activity triggered by electrical impulse from the respiratory center. This study aims to evaluate the EDI changes following caffeine citrate administration and cessation in preterm infants, and whether such changes are affected by different doses used variably in clinical settings.
详细描述
Caffeine citrate has been used as the first-line agent for apnea of prematurity. It works via mechanisms including stimulation of the respiratory center in medulla, increasing sensitivity to carbon dioxide retention, and increment in diaphragmatic activity. The effect of caffeine citrate has been evaluated largely based on parameters concerning clinical symptoms (e.g., decrease in the number of apnea, extubation success, decreased incidence of bronchopulmonary dysplasia) but not quantified parameters of actual diaphragmatic activity. Also, while usual doses of caffeine administration is described in the literature, consensus on the effect of caffeine citrate depending on different dosages has not been established.
The current study aims to evaluate effect of caffeine citrate by quantifying the electrical impulses of diaphragmatic activity using EDI values captured from neurally adjusted ventilatory assist (NAVA) mode.
Out of preterm infants necessitating invasive or non-invasive ventilators, those who are supported by invasive or non-invasive NAVA would be recruited. EDI changes would be monitored for the following timepoints: at the administration of caffeine citrate loading dose, 1st maintenance dose after loading, and at cessation of caffeine citrate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at less than 34 weeks' gestation who are supported by invasive or non-invasive NAVA
排除标准
- •major congenital anomaly, chromosomal or genetic abnormality
研究组 & 干预措施
Low-dose group
Infants receiving low dose caffeine citrate (up to 10mg/kg/day)
干预措施: caffeine citrate (Drug)
High dose group
Infants receiving high dose caffeine citrate (exceeding 10mg/kg/day)
干预措施: caffeine citrate (Drug)
结局指标
主要结局
EDI change after caffeine citrate loading dose
时间窗: 20 minutes before ~ 20 minutes after loading dose of caffeine citrate
changes in EDI min and EDI peak values (μV) after the loading dose administration
EDI change after caffeine citrate cessation
时间窗: 20 minutes before ~ 48 hours after caffeine citrate discontinuation (discontinuation time point definition: 48~96 hours after the last dose of caffeine citrate administration)
changes in EDI min and EDI peak values (μV) after caffeine discontinuation
EDI change after caffeine citrate maintenance dose
时间窗: 20 minutes before ~ 20 minutes after 1st maintenance dose of caffeine citrate
changes in EDI min and EDI peak values (μV) after the 1st maintenance dose
次要结局
- short-term effect of caffeine citrate administration(24 hours before ~ 24 hours after caffeine citrate administration)
研究者
Sook Kyung Yum
Professor
The Catholic University of Korea